MAUDE Adverse Event Report: COOK INC FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH; DYB

Catalog Number KCFW-6.0-35-70-RB-HFANL0-HC

Device Problem Material Separation (1562)

Patient Problems Death (1802); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914)

Event Date 10/16/2019

Event Type  Death  

Manufacturer Narrative

Date of death- reportedly three days after the event, date not confirmed.Pma/510(k) number = pre-amendment.Dr.(b)(6) performed the procedure device evaluated by mfg = device evaluation has begun; however, a conclusion is not yet available.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

As reported, during an unknown procedure, a flexor high-flex ansel guiding sheath separated inside the patient, with a portion of the device remaining in the patient.Reportedly, major arterial damage occurred, including "ripping" of the aorta.The patient's hemoglobin and hematocrit dropped and the patient became hypotensive.The facility called 911 and the patient was transferred to another facility.The patient died three days later.Additional information regarding event details, patient anatomy and outcome has been requested, but is not available at this time.

Manufacturer Narrative

: additional information was provided by dr.Mittal (original reporter) via company representative.Additional information was not provided by the customer despite multiple requests and on-site visits by a cook representative to gather additional information regarding a timeline of events, details of the device separation, patient's anatomy, severity of the aortic tear, and the official cause of death.The intended procedure was a peripheral angiogram via contralateral femoral access; therefore, it is unknown how the device was reported to have damaged the aorta.Reviews of the complaint history, device history record, drawing, instructions for use, manufacturer's instructions, quality control procedures, specifications, and a visual inspection as well as dimensional verification of the returned device were conducted during the investigation.The visual inspection of the returned package confirmed that one flexor high-flex ansel guiding sheath, with biomatter throughout, was returned to cook in two separate sections.Two kinks were noted on the proximal section of the device; and knotted and elongated coil exited the distal end of this section.A small amount of separated inner liner was present within the knotted coils.Elongated coil was also found exiting the proximal end of the distal section of the separated device.It was observed that the flexor coil elongated independent of the polymer catheter shaft materials in both sections.The sheath was compressed and kinked near the tip of the device.It is unknown what actions, if any, were taken to remove the portion of device that was allegedly left in the patient.Additionally, a document-based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should also be noted there were no other reported complaints for this lot number.Furthermore, reviews of the manufacturer's instructions, drawing, specifications, and quality control procedures were conducted, and no gaps were discovered.The ifu provided with this device warns "if resistance is encountered during advancement of flexor sheath, assess cause of resistance and consider dilation of any restriction identified or consider alternate treatment strategy.If flexor sheath is advanced through resistance, force to remove the sheath will be higher, increasing the risk of sheath material or hub separation upon withdrawal." the ifu goes on to also note "reinsertion of the dilator prior to removal of flexor sheath increases the strength of the sheath and lessens the risk of device separation.If resistance is anticipated or encountered during withdrawal or flexor sheath, consider carefully reinserting the dilator prior to continuing removal." a previous root cause investigation determined that the primary contributing factors for this issue include forcing the device through restrictive anatomy, which may cause separation upon removal, and a failure to reinsert the dilator prior to removal as recommended in the instructions for use.As information regarding the reported complaint has been requested but not provided, the definitive cause for this event could not be established.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the risk management file and the risk benefit analysis no further action is required.However, measures are being taken to address this failure mode.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

Additional information was received (b)(6) 2019 and (b)(6) 2019.The 78 year-old female patient had a history of peripheral artery disease.Access was obtained in the femoral artery and a contralateral approach was used up-and-over the bifurcation for a peripheral angiogram of the lower extremity with a possible interventional procedure of the superficial femoral artery.Reportedly, there were no difficulties inserting the sheath into the patient.Information including a timeline of events, details of the device separation, patient's anatomy, severity of the aortic tear, and the official cause of death was requested; however was not provided by the user facility.

Manufacturer Narrative

This mdr is being submitted as having information not previously reported.Additional complaint investigation and record remediation was not performed.Blank fields on this form indicate the information is unknown or unavailable.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH
• Type of Device: DYB
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9310821
• MDR Text Key: 166012561
• Report Number: 1820334-2019-02840
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• PMA/PMN Number: K142829
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 03/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: KCFW-6.0-35-70-RB-HFANL0-HC
• Device Lot Number: 9834452
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2019
• Date Manufacturer Received: 03/26/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization
• Patient Age: 78 YR